IP Library Granted Patent US 11,253,625
Granted Patent B2
US 11,253,625 · App. 16/418,325 · Granted Feb 22, 2022

Ophthalmic device packaging solutions comprising a poloxamine/erythritol mixture

Inventors: Alok Kumar Awasthi (Pittsford, NY); Erning Xia (Penfield, NY); Jennah L. Wolcott (Perry, NY); Ruth Julian (Rochester, NY)
Assignee: Bausch & Lomb Incorporated
A61L12/086A61L12/04A61L12/12B65B25/008C11D3/0078
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Quick Facts
Patent No.
US 11,253,625
App. No.
16/418,325
Granted
Feb 22, 2022
Kind
B2
Abstract

A packaging system for storing ophthalmic devices such as contact lenses and methods for packaging such ophthalmic devices with solutions is disclosed. The packaging system contains an unused, ophthalmic device in an aqueous packaging solution comprising tris(hydroxymethyl)aminomethane or a salt thereof; wherein the solution has an osmolality of at least about 200 mOsm/kg and a pH in the range of about 6 to about 9.

Claims (37)

1. A packaging system for the storage of an ophthalmic device comprising a sealed container that contains an unused, ophthalmic device in an aqueous packaging solution comprising:

(a) tris(hydroxymethyl)aminomethane or a salt thereof;

(b) one or more polysaccharides;

(c) one or more non-ionic surfactants comprising a poloxamine; and

(d) erythritol;

wherein the aqueous packaging solution has an osmolality of at least about 200 mOsm/kg and a pH in the range of about 6 to about 9; and

wherein the packaging system is heat sterilized subsequent to sealing of the packaging system.

2. The packaging system of claim 1 , wherein the tris(hydroxymethyl)aminomethane or a salt thereof is tris(hydroxymethyl)aminomethane hydrochloride.

3. The packaging system of claim 1 , wherein the aqueous packaging solution comprises about 0.001 to about 1 wt. %, based on the total weight of the aqueous packaging solution, of the tris(hydroxymethyl)aminomethane or salt thereof.

4. The packaging system of claim 1 , wherein the aqueous packaging solution further comprises one or more buffer agents.

5. The packaging system of claim 4 , wherein the one or more buffer agents are selected from the group consisting of a phosphate buffer agent, a borate buffer agent, a citrate buffer agent, a MOPS buffer agent and mixtures thereof.

6. The packaging system of claim 4 , wherein the aqueous packaging solution comprises about 0.001 to about 2 wt. %, based on the total weight of the aqueous packaging solution, of the one or more buffer agents.

7. The packaging system of claim 1 , wherein the aqueous packaging solution further comprises one or more of a borate compound, sodium phosphate, and sodium citrate.

8. The packaging system of claim 1 , wherein the one or more polysaccharides comprise an anionic polysaccharide or a non-ionic polysaccharide.

9. The packaging system of claim 1 , wherein the one or more polysaccharides comprise one or more of hyaluronic acid or a salt thereof, chondroitin sulfate, chitosan, aloe vera, carboxymethylcellulose, hemicellulose, hydroxypropyl methyl cellulose, methylcellulose, and ethylcellulose.

10. The packaging system of claim 1 , wherein the one or more polysaccharides comprise one or more of hyaluronic acid, sodium hyaluronate, and potassium hyaluronate.

11. The packaging system of claim 1 , wherein the aqueous packaging solution further comprises one or more additives selected from the group consisting of an antioxidant, a non-ionic surfactant other than a poloxamine, an osmolyte and mixtures thereof.

12. The packaging system of claim 1 , wherein the aqueous packaging solution further comprises one or more additives selected from the group consisting of L-Carnitine, and vitamin E TPGS (tocopherol polyethylene glycol succinate).

13. The packaging system of claim 1 , wherein the poloxamine comprises one or more of a poloxamine di(meth)acrylate, and a reverse poloxamine di(meth)acrylate, and the aqueous packaging solution further comprises one or more additives selected from the group consisting of a poloxamer di(meth)acrylate and a reverse poloxamer di(meth)acrylate.

14. The packaging system of claim 1 , wherein the aqueous packaging solution further comprises one or more additives selected from the group consisting of NaCl, KCl, taurine, glycine, diglycine, alanine; mannitol, sorbitol and propylene glycol.

15. The packaging system of claim 1 , wherein the ophthalmic device is a contact lens.

16. The packaging system of claim 1 , wherein the ophthalmic device is a hydrogel or silicone hydrogel contact lens.

17. The packaging system of claim 1 , wherein the aqueous packaging solution does not contain an effective disinfecting amount of a disinfecting agent.

18. The packaging system of claim 1 , wherein the aqueous packaging solution does not contain a germicide compound.

19. The packaging system of claim 1 , wherein the aqueous packaging solution further comprises one or more additives selected from the group consisting of taurine, carboxymethyl cellulose, hydroxypropylmethyl cellulose, a poly(dimethylacrylamide) polymer having a number average molecular weight of about 10400 to about 65400 and represented by the following structure:

wherein R is CN, OH or H, a polyvinyl pyrrolidone polymer having a number average molecular weight of about 5600 to about 31300 and represented by the following structure:

wherein R is CN, OH or H, a poly(acrylic acid)-grafted-poly(ethylene glycol) polymer represented by the following structure:

wherein m is 10 to 50, a is 10 to 50 and b is 10 to 50, a poly(acrylic acid)-co-poly(ethylene glycol) monoether acrylate copolymer represented by the structure:

wherein n is 10 to 50, a is 10 to 50 and b is 10 to 50, a poly(dimethylacrylamide)-co-poly(ethylene glycol methacrylate) copolymer represented by the following structure:

wherein m is 10 to 50, and n is 10 to 50, a poly(acrylic acid)-2-dimethyl ethylenediamine polymer having the structure:

wherein m is 10 to 50, a poly(acrylic acid)-ethylenediamine deprotected polymer having the structure:

wherein m is 10 to 50, and polyDMA-co-vinyl-4,4-Dimethyl-2-oxazoline-5-one polymer represented by the structure:

wherein m is 10 to 50 and n is 10 to 50.

20. The packaging system of claim 1 , wherein the aqueous packaging solution comprises:

(a) about 0.001 to about 1 wt. %, based on the total weight of the aqueous packaging solution, of the tris(hydroxymethyl)aminomethane or salt thereof;

(b) about 0.001 to about 10 wt. %, based on the total weight of the aqueous packaging solution, of the one or more polysaccharides;

(c) about 0.001 to about 10 wt. %, based on the total weight of the aqueous packaging solution, of the one or more non-ionic surfactants; and (d) 0.20 to 0.50%W/V of erythritol.

Assignments (15)
RELEASE OF SECURITY INTEREST Recorded Nov 20, 2025
From: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
To: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH AMERICAS, INC.
Reel/Frame 073654/0242 →
ASSIGNMENT OF SECURITY INTEREST IN PATENTS PREVIOUSLY RECORDED AT REEL/FRAME (059913/0548) Recorded Aug 14, 2025
From: CITIBANK, N.A., AS RESIGNING AGENT
To: JPMORGAN CHASE BANK, N.A., AS SUCCESSOR AGENT
Reel/Frame 072469/0091 →
PATENT SECURITY AGREEMENT Recorded Jul 1, 2025
From: BAUSCH & LOMB INCORPORATED; ALDEN OPTICAL LABORATORIES, INC.; BAUSCH + LOMB IRELAND LIMITED
To: CITIBANK, N.A., AS NOTES COLLATERAL AGENT
Reel/Frame 071773/0871 →
RELEASE OF SECURITY INTEREST Recorded Apr 8, 2025
From: BARCLAYS BANK PLC, AS COLLATERAL AGENT
To: SOLTA MEDICAL, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH IRELAND LIMITED (F/K/A/ VALEANT PHARMACEUTICALS IRELAND LIMITED); SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD; SANTARUS, INC.; MEDICIS PHARMACEUTICAL CORPORATION; HUMAX PHARMACEUTICAL S.A.; SOLTA MEDICAL IRELAND LIMITED; BAUSCH & LOMB MEXICO, S.A. DE C.V.; BAUSCH+LOMB OPS B.V.; BAUSCH HEALTH AMERICAS, INC.; BAUSCH HEALTH COMPANIES INC.; BAUSCH HEALTH HOLDCO LIMITED; BAUSCH HEALTH MAGYARORSZAG KFT (A/K/A BAUSCH HEALTH HUNGARY LLC); BAUSCH HEALTH POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA (F/K/A VALEANT PHARMA POLAND SPOLKA Z OGRANICZONA ODPOWIEDZIALNOSCIA); BAUSCH HEALTH US, LLC; BAUSCH HEALTH, CANADA INC. / SANTE BAUSCH, CANADA INC.; ICN POLFA RZESZOW SPOLKA AKCYJNA (A/K/A ICN POLFA RZESZOW S.A.); ORAPHARMA, INC.; PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA SPOLKA AKCYJNA (A/K/A PRZEDSIEBIORSTWO FARMACEUTYCZNE JELFA S.A.); SOLTA MEDICAL DUTCH HOLDINGS B.V.; V-BAC HOLDING CORP.; VRX HOLDCO LLC; 1261229 B.C. LTD.; 1530065 B.C. LTD.
Reel/Frame 070778/0199 →
PATENT SECURITY AGREEMENT Recorded Oct 4, 2023
From: BAUSCH & LOMB INCORPORATED
To: CITIBANK, N.A., AS NOTES COLLATERAL AGENT
Reel/Frame 065120/0086 →
OMNIBUS PATENT SECURITY RELEASE AGREEMENT (REEL/FRAME 052589/0884) Recorded Nov 2, 2022
From: THE BANK OF NEW YORK MELLON
To: BAUSCH & LOMB INCORPORATED
Reel/Frame 061849/0001 →
OMNIBUS PATENT SECURITY RELEASE AGREEMENT (REEL/FRAME 056811/0814) Recorded Nov 2, 2022
From: THE BANK OF NEW YORK MELLON
To: BAUSCH & LOMB INCORPORATED
Reel/Frame 061872/0669 →
OMNIBUS PATENT SECURITY RELEASE AGREEMENT (REEL/FRAME 059121/0001) Recorded Nov 2, 2022
From: THE BANK OF NEW YORK MELLON
To: BAUSCH & LOMB INCORPORATED
Reel/Frame 061873/0001 →
RELEASE OF SECURITY INTEREST IN SPECIFIED PATENTS (REEL/FRAME 052589/0813) Recorded Oct 26, 2022
From: BARCLAYS BANK PLC
To: BAUSCH & LOMB INCORPORATED
Reel/Frame 061774/0852 →
PATENT SECURITY AGREEMENT Recorded May 10, 2022
From: BAUSCH & LOMB INCORPORATED
To: CITIBANK, N.A. AS COLLATERAL AGENT
Reel/Frame 059913/0548 →
SECURITY AGREEMENT Recorded Feb 10, 2022
From: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH AMERICAS, INC.
To: THE BANK OF NEW YORK MELLON
Reel/Frame 059121/0001 →
SECURITY INTEREST Recorded Jun 8, 2021
From: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH US, LLC; SOLTA MEDICAL, INC.; MEDICIS PHARMACEUTICAL CORPORATION; SALIX PHARMACEUTICALS, INC.; SALIX PHARMACEUTICALS, LTD.; SANTARUS, INC.; ORAPHARMA, INC.; PRECISION DERMATOLOGY, INC.; BAUSCH HEALTH AMERICAS, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 056811/0814 →
SECURITY INTEREST Recorded May 6, 2020
From: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH IRELAND LIMITED; SALIX PHARMACEUTICALS, LTD; SALIX PHARMACEUTICALS, INC.; SOLTA MEDICAL, INC.
To: BARCLAYS BANK PLC, AS COLLATERAL AGENT
Reel/Frame 052589/0813 →
SECURITY INTEREST Recorded May 6, 2020
From: BAUSCH & LOMB INCORPORATED; BAUSCH HEALTH IRELAND LIMITED; SALIX PHARMACEUTICALS, LTD; SALIX PHARMACEUTICALS, INC.; SOLTA MEDICAL, INC.
To: THE BANK OF NEW YORK MELLON, AS NOTES COLLATERAL AGENT
Reel/Frame 052589/0884 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Feb 25, 2020
From: AWASTHI, ALOK KUMAR; XIA, ERNING; WOLCOTT, JENNAH L.; JULIAN, RUTH
To: BAUSCH & LOMB INCORPORATED
Reel/Frame 051920/0254 →